Amgen, UCB Group's Romosozumab Showed Significant Results in Phase III Study
September 19, 2016
By Alex Keown, BioSpace.com Breaking News Staff
THOUSAND OAKS, Calif. – Amgen has some good news for older women concerned about osteoporosis. Its Phase III drug romosozumab reduced vertebrae fracture rates by 73 percent compared to placebo after one year of taking the medication.
Romosozumab is being developed by Amgen and Belgium-based UCB. Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.
The Phase III FRAME study met both primary and secondary endpoints, reducing both vertebrae fractures as well as reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women.
Osteoporosis-related fragility fractures are common. In the United States, one in two women over the age of 50 will experience an osteoporotic fracture. Data shows that only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post fracture, Amgen said in a statement.
"A vertebral fracture due to osteoporosis can be a life-altering event, and the risk of these kinds of fractures will be a growing burden as our society ages," Sean Harper, executive vice president of Research and Development at Amgen, said in a statement. "These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months."
In July, Amgen and UCB submitted a Biologics License Application to the U.S. Food and Drug Administration, based on interim Phase III results.
The FRAME study included 7,180 women who received either monthly 210 mg subcutaneous injections of romosozumab or placebo for one year, followed by 12 months of open-label denosumab treatment for both arms. After one year, the group who received romosozumab showed the 73 percent reduction of risk of vertebrae fractures compared to the placebo group, Amgen said in a statement. Through 24 months, the study showed that romosozumab followed by denosumab reduced the relative risk of new vertebral fracture by a statistically significant 75 percent compared to placebo followed by osteoporosis-drug denosumab. Additionally, patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture through 12 months compared to those receiving placebo, the companies said.
UCB and Amgen plan to discuss these results with global regulators in anticipation of a potential filing in 2016.
Iris Loew-Friedrich, chief medical officer and executive vice president of UCB said a deeper understanding of the results will “help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis."
In the initial 12-month treatment period, the most commonly reported adverse events in both arms (greater than 10 percent) were arthralgia, nasopharyngitis and back pain.